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A Study on the Safety of Oliceridine in Hysteroscopic Surgery

A Study on the Safety of Oliceridine in Hysteroscopic Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111411
Enrollment
Unknown
Registered
2025-10-30
Start date
2025-10-30
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Undergo hysteroscopic surgery

Interventions

Oliceridine group:Administer propofol at a dose of 2 mg/kg based on patient body weight, followed by intravenous administration of remimazolam 1 mg
ensure slow injection over approximately 10 seconds. Begin hysteroscopic procedures once the MOAA/S score is =60 mmHg, with fluctuations not exceeding 20% of baseline
keep heart rate between 50 and 100 beats per minute, with fluctuations not exceeding 20% of baseline. If significant increases in MAP or heart rate (exceeding 20% above baseline) occur, indicating ina
Sufentanill group:Administer propofol at a dose of 2 mg/kg based on patient body weight, followed by intravenous injection of sufentanil 5 µg

Sponsors

Mindong Hospital of Ningde City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18~65 years, BMI (Body Mass Index) 18<=BMI<=27 kg/m^2; 2. ASA (American Society of Anesthesiologists) grade: I~II, estimated operation time <1 hour; 3. Patients agree to participate in this study and have good compliance; 4. The patient underwent hysteroscopic diagnosis and treatment, and the anesthesia method was non-intubated general anesthesia.

Exclusion criteria

Exclusion criteria: 1. Suffering from poorly controlled hypertension, diabetes, or airway-related diseases such as asthma; 2. Severe liver and kidney insufficiency; 3. History of allergy to anesthetics; 4. Regular long-term use of glucocorticoids, analgesics, or psychiatric drugs within the past 3 months; or a history of drug abuse; 5. Those who refuse to participate in this study or have difficulties in communication; 6. Subjects with any other factors that the investigator believes are inappropriate for participation in this clinical study.

Design outcomes

Primary

MeasureTime frame
Incidence of respiratory depression;

Secondary

MeasureTime frame
Incidence of body movement;Incidence of nausea and vomiting;PACU Discharge Time; The number of additional doses and dosage of analgesic drugs (oliceridine and sufentanil); The number of doses and dosage of tramadol;The dosage of propofol;Other adverse reactions and incidence rate;Incidence of hypotension;QoR-15 scale score on the first day after surgery;Pittsburgh sleep quality index (PSQI) score three months after surgery;Levels of inflammatory markers IL-6 and TNF-a before surgery and on postoperative day 1;Arterial partial pressure of oxygen, partial pressure of carbon dioxide, pH, and oxygenation index at post-anesthesia and at the end of surgery;

Countries

China

Contacts

Public ContactLiang Yagui

Mindong Hospital of Ningde City

181489164@qq.com+86 157 1500 6999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026